INSTRUMENT 2199-2022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327244861), received between Jul 11, 2022 and Sep 27, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Fracture; Fracture

  DURING SURGERY THE ITEM FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328449 ↗
• MalfunctionJul 11, 2022Fracture; Fracture

  DURING THE REVISION CASE, PART OF THE CONSTRAINED LINER IMPACTOR FLANGE BROKE. FOLLOWING THE CASE, AN S9 REPLACEMENT WAS LODGED TO REPLACE THE INSTRUMENT. THEATRE STAFF ALERTED STRYKER PERSONNEL THAT DURING THE SEROMA DEBRIDEMENT, A PIECE OF PLASTIC DEBRIS WAS REMOVED FROM THE PATIENTS HIP, ALLEGED TO HAVE ARISEN FROM THE CONSTRAINED LINER IMPACTOR USED AND BROKEN DURING REVISION CASE.

  Patient problems: Seroma

  MAUDE report 14983062 ↗
• InjuryJul 11, 2022Fracture; Fracture

  PRIMARY TOTAL HIP REPLACEMENT (EXETER/TRIDENT) COMPLETED. PRIMARY REVISED DUE TO STABILITY. LINER EXCHANGED FROM TRIDENT 36D 0DG LINER TO TRIDENT 22.2D CONSTRAINED LINER USING 22.2MM CONSTRAINED IMPACTOR. DURING THE REVISION CASE, PART OF THE CONSTRAINED LINER IMPACTOR FLANGE BROKE. FOLLOWING THE CASE, AN REPLACEMENT WAS LODGED TO REPLACE THE INSTRUMENT. LATER THEATRE STAFF EMAILED A BOOKING REQUEST FOR "DEBRIDEMENT OF SEROMA, EXETER DAIR BACKUP" FOR THE AFOREMENTIONED PATIENT. THE SEROMA DEBRIDEMENT PROCEEDED. THEATRE STAFF ALERTED STRYKER PERSONNEL THAT DURING THE SEROMA DEBRIDEMENT, A PIECE OF PLASTIC DEBRIS WAS REMOVED FROM THE PATIENTS HIP, ALLEGED TO HAVE ARISEN FROM THE CONSTRAINED LINER IMPACTOR USED AND BROKEN DURING THE PREVIOUS CASE . THIS IS FOR THE "DEBRIDEMENT OF SEROMA".

  Patient problems: Seroma

  MAUDE report 14982980 ↗